# FDA recall Z-1001-2020

> **Clinical Diagnostic Solutions, Inc.** · Class II · device recall initiated 2020-01-02.

## Product

Medonic M-Series Hematology Analyzer  M16S BD ABR US  Product code: 1400075;   OUS Product code 1400011

## Reason for recall

A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.

## Distribution

Worldwide distribution.  US Nationwide, Venezuela, Africa, Italy, Brazil, and Ukraine.  No governmental, Canadian, or Mexican consignees.

## Key facts

- **Recall number:** Z-1001-2020
- **Recalling firm:** Clinical Diagnostic Solutions, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-02
- **Report date:** 2020-02-12
- **Termination date:** 2022-11-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plantation, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1001-2020

## Citation

> AI Analytics. FDA recall Z-1001-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-1001-2020. Source: US FDA. Licensed CC0.

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